510(k) Report

Devices descending from K013381

470 later devices reach Advanced Lung Analysis-1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+4K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+4K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+4K113620Myrian 1.11Intrasense20126—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+4K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+4K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+4K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+4K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+5K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K252029AI-CVDHeartLung Corporation20250—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202990NinesMeasureNines, Inc.20211—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K202700ART-PlanTherapanacea20215—
+5K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+5K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+5K200323AutoContourRadformation, Inc.20207—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K190868Cleerly LabsCleerly, Inc.20197—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K171754NovaPACSNovarad Corporation201741
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K163574Multi Modality ViewerVital Images, Inc.20171—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K151233MonacoImpac Medical Systems, Inc.201569
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+5K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—